Identity
- Trade Name
- HEATmarker® Time-Temperature Indicators: F12 FDA UDI
- Generic Name
- Medical product temperature point indicator, thermochemical FDA UDI
- Device Name
- Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C. FDA UDI
- Model / Reference
- F12 FDA UDI
- Description
- Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 12 months at 5°C. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852282007037 FDA UDI
- FDA Product Code
- JOJ FDA UDI
- GMDN Term
- Medical product temperature point indicator, thermochemical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical product temperature point indicator, thermochemical
HEATmarker® Time-Temperature Indicators: F12 by Temptime Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical product temperature point indicator, thermochemical.
- HemoTemp — LCR HALLCREST, LLC. · Class II
- HemoTemp II — LCR HALLCREST, LLC. · Class I
- HEATmarker® Time-Temperature Indicators: F36 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: CT12 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: F3 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: CT6 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: CT3 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: CT24 — Temptime Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Temptime Corporation
Sources (1)
- FDA UDI 37e938d6-a618-4e5b-8fd7-9d7515255f76 35 fields · synced Jun 8, 2026